MedTech CNC Validation Engineer

TechDigital Group; Warsaw (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading MedTech firm in Indiana is seeking a skilled professional to validate CNC equipment and related processes used in manufacturing medical devices. This role requires proficiency in validation documentation and compliance with GMP/ISO standards. Candidates should have a Bachelor’s degree in engineering and 3–7 years of experience in CNC manufacturing. The position offers a dynamic work environment with opportunities for collaboration across various departments.

Qualifications

• 3–7 years in CNC manufacturing and equipment validation in a regulated environment.
• Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820.
• Experience with metrology, calibration, and measurement system analysis.

Responsibilities

• Develop and execute validation activities for CNC machines.
• Create and maintain validation documentation (IQ, OQ, PQ).
• Lead the Master Validation Plan and conduct risk assessments.
• Collaborate with various departments to qualify new machines.
• Analyze process data to demonstrate repeatability and accuracy.
• Provide training to operators and maintenance staff.

Skills

Manufacturing Process

CAM programming

GD&T

Product design

New product introduction

CNC machinery

Statistical tools (Minitab, JMP)

Risk management (ISO 14971)

Education

Bachelor’s degree in mechanical engineering

Bachelor’s degree in Manufacturing Engineering

Bachelor’s degree in Biomedical Engineering

Tools

Minitab

JMP

MasterControl

ETQ

Job description

A leading MedTech firm in Indiana is seeking a skilled professional to validate CNC equipment and related processes used in manufacturing medical devices. This role requires proficiency in validation documentation and compliance with GMP/ISO standards. Candidates should have a Bachelor’s degree in engineering and 3–7 years of experience in CNC manufacturing. The position offers a dynamic work environment with opportunities for collaboration across various departments.